Data / Medical devices / United States / Custom Assemblies, Inc.

Custom Assemblies, Inc.: FDA-registered device maker in Pine Level, NC, United States, 1 510(k) clearance

Name: Custom Assemblies, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Custom Assemblies, Inc. is registered with the FDA (registration 1063382) in Pine Level, NC, United States. It lists 15 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 4, 2000. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1063382
FEI number: 3000718854
Address: 330 East Main Street, Pine Level, NC, United States, 27568
Owner or operator: CUSTOM ASSEMBLIES, INC. (9026626)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: January 20, 2012
Registered through: 2026
Brand names listed: Balloon Catheter, Container, Specimen, Non-Sterile, Drain Bag, Drape, Surgical Exempt, General Surgery Tray, IV Set, Injection Cannula, Microtome Accessories and more

Devices it lists

Device	Product code	Class	Role	Source
Cannula, Injection	FGY	1	Manufacturer	accessdata.fda.gov
Catheter, Balloon Type	GBA	1	Repackager or relabeler	accessdata.fda.gov
Container, Specimen, Non-Sterile	NNI	1	Manufacturer	accessdata.fda.gov
Container, Specimen, Sterile	FMH	1	Manufacturer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Repackager or relabeler	accessdata.fda.gov
General Surgery Tray	LRO	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Holder, Needle, Gastroenterologic	FHQ	1	Repackager or relabeler	accessdata.fda.gov
Holder, Needle; Orthopedic	HXK	1	Manufacturer	accessdata.fda.gov
Microtome, Accessories	IDL	1	Repackager or relabeler	accessdata.fda.gov
Restraint, Wheelchair, Non-Protective	KID	1	Repackager or relabeler	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Manufacturer	accessdata.fda.gov
System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile	NNZ	1	Repackager or relabeler	accessdata.fda.gov
Table And Attachments, Operating-Room	BWN	1	Manufacturer	accessdata.fda.gov
Tubing, Noninvasive	GAZ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Tubing, Pressure And Accessories	BYX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 4, 2000	K993463	INTRAVASCULAR ADMINISTRATION SET	FPA	Substantially Equivalent	Custom Assemblies, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 15, 2017	77962	Class II	Terminated	Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY (b) CMS-5832-R1 Custom Safety Mammo Biopsy Tray (c) CMS-4108 Multipurpose Safety Tray (d) CMS-3141-R6 C	The firm manufactured and distributed custom surgical kits which contained BD SafetyGlide" 22GA 1 inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection.	accessdata.fda.gov

Compare with other makers

Updated August 22, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.